i-STAT TBI Cartridge with the i-STAT Alinity System
FDA 510(k) clearance K234143 · decided 2024-03-27
Clearance details
- K-number
- K234143
- Device name
- i-STAT TBI Cartridge with the i-STAT Alinity System
- Applicant
- Abbott Point of Care
- Decision
- Substantially Equivalent
- Date received
- 2023-12-29
- Decision date
- 2024-03-27
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- QAT
- Device class
- 2
- Regulation number
- 866.5830
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Princton, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VIDAS TBI (GFAP, UCH-L1) (K240279) | bioMerieux, Inc. | 2024-05-01 |
| TBI (K232669) | Abbott Laboratories | 2023-09-29 |
| Traumatic brain injury (TBI) test (K223602) | Abbott Laboratories | 2023-03-02 |
| i-STAT TBI Plasma cartridge with the i-STAT Alinity System (K201778) | Abbott Laboratories | 2021-01-08 |
| Banyan BTI (DEN170045) | Banyan Biomarkers, Inc. | 2018-02-14 |
Recalls involving this device
No recalls on record reference this clearance.